Miele PG 8527 User manual

Operating instructions
Washer-disinfector
PG 8527 / PG 8528
To avoid the risk of accidents or
damage to the machine it is
essential to read these instructions
before it is installed, commissioned
and used for the first time. M.-Nr. 09 338 730
en - GB, AU, NZ

2

Warning and safety instructions .....................................6
Correct application ...............................................6
Using accessories ..............................................10
Symbols on the machine .........................................10
Disposing of your old machine .....................................10
Intended Use ....................................................11
User profile ......................................................12
Guide to the machine .............................................13
Controls .........................................................16
Display ..........................................................18
An example of a selected list ......................................18
An example of a programme sequence display .......................19
Context menu ....................................................20
Change display language ...........................................21
Changing operating level ...........................................22
Delay start .......................................................24
Switch heating method .............................................26
Current faults .....................................................26
Load items .......................................................26
Automatic mobile unit recognition...................................27
Areas of application...............................................28
Protein test .......................................................28
Loading the machine ...............................................29
Surgical instruments (OP) ...........................................30
Ophthalmology ...................................................31
Anaesthetic instruments (AN) ........................................32
Baby bottles (BC) .................................................33
Operating theatre shoes (OS) ........................................34
Laboratory glassware (LG) ..........................................35
Chemical processes and technology.................................37
Dispensing liquid chemical agents ..................................42
Dispensing systems................................................44
"Fill DOX [X] container" message ...................................44
Fill the containers with the relevant agent ............................44
"Check dispensing system [X]".....................................45
Venting the dispensing system.....................................45
Contents
3

Operation .......................................................46
Master switch.....................................................46
Switching on .....................................................46
Starting the programme.............................................47
Programme sequence ..............................................49
At the end of a programme ..........................................49
Switching off .....................................................49
Cancelling a programme ............................................49
Interrupting a programme ...........................................50
Barcode scanner (optional) ........................................51
Barcode scanner functions ..........................................51
Scanning the barcode with a conveyor system connected ...............52
Scan loading operator ..............................................53
To cancel Scan loading operator ...................................53
Scan unloading operator ............................................54
Skipping Scan unloading operator ..................................54
Scanning the load .................................................55
Cancelling "Scan the load" ........................................56
Skipping "Scan the load"..........................................56
Accept scanned loads ...........................................56
Scanned loads....................................................58
Adding scanned loads ...........................................59
Displaying scanned loads ........................................60
Deleting scanned loads ..........................................61
Moving scanned loads ...........................................62
Process documentation ...........................................63
Maintenance .....................................................64
Periodic checks ...................................................64
Process validation .................................................65
Routine checks ...................................................65
Cleaning the filters in the wash cabinet.................................66
Cleaning the flat filter ............................................66
Cleaning the circulation pump filters ................................67
Cleaning the spray arms ............................................68
Cleaning the controls and the (optional) glass door .......................69
Cleaning the front of the machine .....................................69
Contents
4

Cleaning the wash cabinet ..........................................69
Cleaning the door seals.............................................69
Mobile units, modules and inserts .....................................70
Integrated printer (optional)..........................................71
Renewing the paper roll ..........................................71
Renewing the ribbon.............................................71
After sales service ................................................72
Electrical connection .............................................73
Plumbing........................................................74
Technical data ...................................................75
Optional extras...................................................76
Special processes - OXIVARIO and ORTHOVARIO .....................77
Intended Use .....................................................77
Areas of application .............................................77
Warning and Safety instructions ......................................78
Connecting the H2O2solution container ................................79
Special version with DK + WRG .....................................80
Description.......................................................80
Areas of application .............................................80
Warning and Safety instructions ......................................81
Standardprogrammes ..............................................82
Disposal of your old machine.......................................83
Contents
5

This washer-disinfector complies
with all relevant local and national
safety requirements. Please note
that incorrect use can lead to
personal injury and damage to
property.
To avoid the risk of accidents and
damage to the machine, please
read these instructions carefully
before starting to use it. Keep these
instructions in a safe place for
reference, and pass them on to any
future user.
Correct application
~This washer-disinfector is designed
for use with the applications described
in these Operating Instructions only.
Alterations or conversions to the
machine, or using it for purposes other
than those for which it was designed,
are not permitted and could be
dangerous.
This machine must only be used for
cleaning and disinfecting instruments,
medical devices and laboratory
equipment if the manufacturer has
stated that they are suitable for
machine reprocessing. Manufacturer's
cleaning and maintenance instructions
for instruments etc. must also be
observed.
Miele cannot be held liable for damage
caused by improper or incorrect use or
operation of the machine.
~This washer-disinfector is intended
for stationary, indoor use only.
Please pay attention to the following
notes to avoid injury and damage.
~This machine should be
commissioned and then maintained by
a Miele approved and trained service
technician only. A Miele service
contract is recommended to ensure
compliance with GLP Guidelines and
the Medical Device Directive.
Unauthorised repairs could be
dangerous, for which the manufacturer
cannot be held liable.
~Do not install the machine in an area
where there is any danger of explosion
or of freezing conditions.
~The electrical safety of this machine
can only be guaranteed if connected to
a correctly installed earthing system on
site. It is most important that this basic
safety requirement is observed and
regularly tested, and where there is any
doubt the on-site wiring system should
be inspected by a qualified electrician.
The manufacturer cannot be held liable
for damage or injury caused by the lack
of or inadequacy of an effective
earthing system (e.g. electric shock).
~A damaged or leaking machine
could be dangerous. Disconnect the
machine from the mains immediately
and call the Miele Service Department.
~Personnel operating the machine
should be trained regularly. Untrained
personnel must not be allowed access
to the machine or its controls.
Warning and safety instructions
6

~Take care when handling chemical
agents such as cleaning agent,
neutralising agent, rinsing agent etc.
These may contain irritant or corrosive
ingredients.
Please follow the manufacturer's safety
instructions. Wear protective gloves
and goggles. With all chemical agents,
the manufacturer's safety instructions
and safety data sheets must be
observed.
~The washer-disinfector is designed
for operation with water and
appropriate chemical agents only.
Organic solvents and flammable liquid
agents must not be used in this
machine.
These could cause an explosion,
damage rubber and plastic
components in the machine, and cause
liquids to leak out of the machine.
~The water in the cabinet must not be
used as drinking water.
~Be careful when sorting items with
sharp pointed ends and positioning
them in the machine that you do not
hurt yourself or create a danger for
others. Sharp knives etc. should be
placed in baskets with the pointed ends
facing downwards.
~Please be aware that the
washer-disinfector may be operating at
high temperatures. If the door is
opened by circumventing the lock there
is the danger of burning, scalding or
chemical burning. If disinfecting agents
are used there is a danger of inhaling
toxic vapours.
~Where there is a risk of toxic or
chemical substances occuring in the
suds solution (e.g. aldehyde in the
disinfecting agent), it is essential to
regularly check door seals and make
sure that the steam condensor is
functioning correctly.
Opening the machine door during a
programme interruption carries
particular risks in such circumstances.
~Should personnel accidentally come
into contact with toxic vapours or
chemical agents, follow the emergency
instructions given in the chemical agent
manufacturer's safety data sheets.
~Mobile units, modules, inserts and
the load must be allowed to cool down
before they are unloaded. Any water
remaining in containers could still be
very hot. Empty them into the wash
cabinet before taking them out.
~After using the hot air drying unit,
open the door to allow the everything in
the cabinet from the load itself to the
mobile units, modules and inserts to
cool down.
~If the boiler has been programmed
to "BOILER READY", be particularly
careful of hot water and steam when
opening the door. Danger of burning or
scalding. The inlet to the wash cabinet
is located, as viewed from the unclean
side, underneath the basket runner on
the right hand side.
~Steam heating is permissible up to a
pressure of 1000 kPa (10 bar). This
corresponds to a water steam
temperature of 179°C.
Warning and safety instructions
7

~Never clean the machine or near
vicinity with a hose or a pressure
washer.
~The machine must be disconnected
from the mains electricity supply before
any maintenance or repair work is
carried out. Do not reconnect it until the
maintenance or repair work has been
successfully completed.
The following points should be
observed to assist in maintaining
quality standards for reprocessing
medical devices and sensitive
laboratory glassware, and to avoid
injury to patients or damage to
equipment.
~If the machine is being used for
disinfection in accordance with official
regulations on the control of epidemics,
the steam condenser and its
connections to and from the wash
cabinet must be cleaned and
disinfected whenever any repairs are
carried out or parts replaced.
~If it is necessary to interrupt a
programme in exceptional
circumstances, this may only be done
by authorised personnel.
~The standard of cleaning and
disinfection in the disinfection
programmes for medical devices must
be routinely confirmed by the user. The
process must be thermo-electrically
validated on a regular basis, and
checked against documented control
results. Chemical disinfecting
procedures must also be validated
using chemical or bio indicators.
~For thermal disinfection, use
temperatures and temperature holding
times to achieve the required infection
prophylaxis in accordance with current
health and safety regulations.
~Medical devices are reprocessed by
thermal disinfection. Items which are
not heat-resistant, e.g. operating
theatre (OP) shoes, can be
reprocessed with the CHEM-DISIN
programme with the addition of a
chemical disinfection agent.
The range of effective disinfection is
based on claims made by the producer
of the disinfecting agent, whose advice
regarding handling, use and
effectiveness must be observed. This
type of chemo-thermal procedure is not
suitable for reprocessing medical
devices.
~Chemical agents could, under
certain conditions, cause damage to
the washer-disinfector. Follow the
recommendations of the chemical
agent manufacturer. In the event of any
damage or material deterioration
please contact Miele.
~Do not use any abrasive chemical
agents in washer-disinfectors as these
will cause erosion to machine
components (e.g. spray arm bearings).
If using abrasive chemical agents in the
manual pre-preparation of containers or
instruments, ensure that no trace of
these remain prior to reprocessing in
the washer-disinfector.
Warning and safety instructions
8

~Pre-treatments with cleaning or
disinfecting agents can create foam, as
can certain types of soiling and
chemical agents. Foam can have an
adverse effect on the disinfection and
cleaning result.
~Foam must not be able to escape
from the wash cabinet. It would hinder
the correct functioning of the machine.
~The process used should be
checked regularly by the supervisor to
monitor foaming levels.
~To avoid the risk of damage to the
machine and any accessories used
with it caused by chemical agents,
soiling and any reaction between the
two please read the notes in "Chemical
Processes and Technology".
~Where a chemical agent is
recommended on technical application
grounds (e.g. a cleaning agent), this
does not imply that the manufacturer of
the machine accepts liability for the
effect of the chemical on the items
being cleaned.
Please be aware that changes in
formulation, storage conditions etc.
which may not be publicised by the
chemical manufacturer, can have a
negative effect on the cleaning result.
~When using cleaning agents and
specialised products it is essential that
the manufacturer's instructions are
observed. Only use the product for the
application described by the
manufacturer, to avoid any material
damage or the occurrence of strong
chemical reactions.
~In critical applications where very
stringent requirements have to be met,
it is strongly recommended that all the
relevant factors for the process, such
as chemical agents, water quality etc.
are discussed with Miele.
~If cleaning and rinsing results are
subject to particularly stringent
requirements (e.g. chemical analysis),
a regular quality control test must be
carried out by the supervisor to ensure
that the required standards of
cleanliness are being achieved.
~Mobile units, modules and inserts
should only be used for the purpose
they are designed for.
Hollow instruments must be thoroughly
cleaned, internally and externally.
~Empty any containers or utensils
before arranging them in the machine.
~Do not allow any remains of acids or
solvents, and in particular hydrochloric
acid or chloride solutions, to get into
the wash cabinet. Similarly avoid any
materials with a corrosive effect. The
presence in compounds of any solvents
should be minimal (especially those in
hazard class A1).
~Ensure that solutions or steam
containing hydrochloric acid do not
come into contact with the steel outer
casing of the machine, to avoid any
corrosion damage.
~After carrying out any work on the
mains water system, the water supply
system to the washer-disinfector must
be vented.
Otherwise, the components in the
machine may become damaged.
Warning and safety instructions
9

~Please follow the advice on
installation in these instructions and the
separate Installation Instructions.
Using accessories
~Only use genuine Miele original
accessories with this washer-disinfector
and only use them for the purposes
they are designed for. Consult Miele on
the type and application of such
equipment.
~Only use Miele mobile units,
modules and inserts in this machine.
Using accessories made by other
manufacturers, or making modifications
to Miele accessories, can result in
unsatisfactory cleaning and disinfecting
results, for which Miele cannot be held
liable. Any resultant damage would also
invalidate the machine guarantee.
~Only use chemical agents which
have been approved by their
manufacturer for use in the application
you are using. The chemical agent
manufacturer is responsible for any
negative influences on the material the
load is made from and for any damage
they may cause to the machine.
Symbols on the machine
Warning:
Observe the operating
instructions.
Warning:
Danger of electric shock.
Please observe the
instructions given in
"Special version with
DK + WRG".
Disposing of your old machine
~Please note that the machine may
have contamination from blood or other
bodily fluids in it and must be
decontaminated before disposal.
For environmental and safety reasons
ensure the machine is completely
drained of any residual water, chemical
residues and cleaning agent. Observe
safety regulations and wear safety
goggles and gloves.
Make the door lock inoperative, and
block or disable the door in such a way
that children cannot accidentally shut
themselves in the cabinet. Then make
appropriate arrangements for the safe
disposal of the machine. For tank
system machines ensure that any water
is emptied out of the tank before it is
moved.
The manufacturer cannot be held
liable for damage caused by
non-compliance with these Warning
and Safety instructions.
Warning and safety instructions
10

Re-usable medical devices, laboratory
equipment and accessories can be
cleaned, rinsed, disinfected and dried
in this Miele washer-disinfector.
Follow the manufacturer's instructions
(according to EN ISO 17664) on how to
reprocess their items by machine.
Examples of application areas:
–surgical instruments,
–minimally invasive surgical
instruments,
–anaesthetic and intensive care
instruments,
– baby bottles and teats,
– maintenance and waste containers,
– operating theatre shoes,
or
– laboratory equipment used in
research and development,
– laboratory equipment used in areas
of analysis and specimen taking,
–laboratory equipment used in
micro-biology and biotechnology.
The type of laboratory equipment which
can be reprocessed ranges from
evaporating dishes to centrifugal test
tubes.
Reprocessing medical devices and
laboratory equipment by machine
achieves reproducible results, and
should be used in preference to
reprocessing them by hand.
Where disinfection is required for the
protection of staff and/or patients, a
thermal disinfection programme, e.g.
the DESIN vario TD programme, should
be selected.
- Except for operating theatre (OP)
shoes which are not heat-resistant, for
which the CHEM-DISIN programme
should be used.
The parameters for thermal disinfection
according to EN ISO 15883-1 (A0
concept) vary depending on the
disinfection standard required. They
are 80 °C (+ 5 °C, - 0 °C) with a 10 min
holding time (A0600) or 90 °C (+ 5 °C,
- 0 °C) with a 5 min holding time (A0
3000). An A0value of 3000 is suitable
for deactivating the HBV virus.
National health and safety regulations
regarding disinfection must also be
observed.
The cleaning programme as well as any
chemical agents must be chosen
according to the type of soiling and
load being reprocessed.
The agents used for reprocessing the
products should be selected to suit the
level of cleaning required as well as the
method of analysis used.
Intended Use
11

The cleaning result must ensure that
instruments can be disinfected
correctly, that no residues are left
behind, that subsequent sterilisation
can be carried out and that the
instruments can be used again safely.
Medical devices are best reprocessed
using the DESIN vario TD programme,
or the ORTHOVARIO or OXIVARIO
programme where applicable.
The use of a suitable carrier (mobile
unit, module, insert etc.) is important to
ensure the adequate cleaning of
instruments and medical devices.
Examples are given in the section
"Areas of application".
The washer-disinfector is programmed
to carry out the final rinse with mains
water or processed water (e.g. Aqua
destillata, pure water, de-ionised water,
demineralised water in the quality
required by the application). The water
quality is of particular importance for
applications requiring analytically clean
laboratory glassware.
The machine qualifies for the validating
of processes in accordance with EN
ISO 15883.
User profile
Daily operatives
Operatives using the machine daily
should be familiar with the basic
functions of the machine and its loads
and trained on a regular basis. They
require basic knowledge about how to
reprocess medical devices by
machine.
Generally they would be using the
machine in Operating levels A and C.
Supervisory level
More advanced functions such as
interrupting or cancelling a programme
requires more in-depth knowledge
about machine reprocessing of medical
devices.
This level of functionality is carried out
in Operating level B.
Service and Administration
Changes to reprocessing methods and
alterations to the washer-disinfector,
e.g. concerning the type of accessories
used in it or the conditions in which the
machine is used require additional
knowledge about the machine.
Validation also requires additional
knowledge about how to reprocess
medical devices, which procedure to
use and any Standards and regulations
that may apply.
Service and validation work is carried
out using Operating level D.
Intended Use
12

Unclean side
aHousing for hot air drying unit TA
and / or steam condenser DK
b"Profitronic" electronic controls (see
also "Programming manual")
cMultiport
dMaster switch
eScanner holder (optional)
fService panel
gDocking facility for Transfer trolley
MF 27/28
hDoor shown closed
Guide to the machine
13

Unclean side
aDoor shown open
bDocking facility for mobile units and
modules
cLower spray arm
dFilter combination
eContainers for dispensing systems
DOS 1 - DOS 4
Guide to the machine
14

Clean side (PG 8528 only)
aDoor shown closed
bService panel with docking facility for
Transfer trolley MF 27/28
cMultiport
dScanner holder (optional)
ePrinter (optional)
fDoor release
gDisplay
Guide to the machine
15

Controls
aOn/Off button s
For switching the machine on and off
baDoor release button
For opening and closing the door
cDisplay
The display will switch off automatically after approximately
10 minutes when the washer-disinfector is not in operation.
Press any button to switch the display back on again.
Faults occurring during operation will be indicated by a
number in the display.
The fault numbers are listed in the Programming manual.
Guide to the machine
16

dPC service interface 9
For testing and updating the programme data
ehStart button
For starting the programme
f+C (Clear) button used to
– return to the previous level
– delete entries already made
– cancel a programme
gand i- e buttons (Selector buttons) used to
– move the highlighting in the display
– change highlighted values
– scroll
– call up context menus
– show user defined operating parameters during the
programme
hOK button
– confirm highlighted options or selected values
– acknowledge error messages
– acknowledge dialogue messages
– call up the A0graph during a programme.
– view the temperature graph during a programme.
Guide to the machine
17

Display
The display can show the following, depending on the
operating level:
–the programme / programme overview
–the programming menu
–the Settings Jmenu
The Settings menu Jis used to alter the
washer-disinfector's profitronic controls to suit different
requirements. See the Programming manual for more
details.
An example of a selected list
Programme overview B
CHANGE-TA-FINE
DES-VAR-TD
DES-VAR-TD-AN #
The -ebuttons are used to select the options.
The selector buttons -e move the highlighting in the display.
The OK button is used to confirm a message or setting and
also to move to the next menu or to another menu level.
To select an option use the selector buttons -e to highlight it
and then confirm your selection with the OK button.
The display shows a maximum of three options or choices. A
scroll bar on the right hand side of the display indicates that
more options or choices are available. The -e selector
buttons are used to display these.
The end of the list is marked with a dotted line. The last entry
in the list is shown above the line and the first, below it.
Guide to the machine
18

An example of a programme sequence display
DES-VAR-TD A
Main wash 55.2 °C
Time remaining 0:35 h
During a programme, the display shows the following:
–the name of the programme
–the operating level
–the programme block
–the water temperature
(the air temperature in the "Drying" programme block)
– the estimated programme duration remaining or the
programme duration already elapsed
– any relevant fault messages and notes.
Guide to the machine
19

Some functions can be called up at any time via a context
menu, irrespective of the operating level:
–Change display language,
–Change operating level,
–Enter delay start,
–(On convertible washer-disinfectors)
Switch heating method,
–Link the load items with the barcode scanner.
In addition, current fault messages will be displayed in
operating level D (if applicable).
^Press the - e buttons at the same time for at least 3
seconds to call up the context menu.
The context menu will appear in the display:
Context menu B
Scanned loads
Change display language F
Change operating level #
The -ebuttons are used to select the options.
Context menu
20